Actively Recruiting

Phase 1
Phase 2
Age: 16Years - 55Years
FEMALE
NCT06826859

Daily Aspirin vs Split Dosing in High-risk Pregnancies (DASH)

Led by Thomas Jefferson University · Updated on 2025-07-17

400

Participants Needed

1

Research Sites

235 weeks

Total Duration

On this page

Sponsors

T

Thomas Jefferson University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Aspirin is recommended in high risk patients to reduce the risk of preeclampsia and preterm birth, which are leading causes of both maternal and neonatal morbidity and mortality, but up to 20% will have these adverse outcomes despite therapy. Gaps in knowledge regarding pregnancy specific aspirin pharmacology and the relationship of aspirin response and pregnancy outcome, along with a lack of consensus on aspirin dosing has limited the effective use of this intervention. The investigators aim to apply principles of clinical pharmacology to determine how to optimally utilize this low cost medication to improve maternal/child health outcomes. This is a Phase I/II randomized controlled trial of high risk pregnancies recommended aspirin; participants will be randomized to take aspirin either 162mg once daily, or 81mg twice a day. Outcomes evaluated will include the difference in aspirin response between these two dosing regimens, the individual factors that impact aspirin pharmacology in pregnancy, and evaluate markers or aspirin response that may be associated with pregnancy outcome.

CONDITIONS

Official Title

Daily Aspirin vs Split Dosing in High-risk Pregnancies (DASH)

Who Can Participate

Age: 16Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Singleton pregnancy less than 16 weeks gestation confirmed by ultrasound
  • At least 1 high risk factor or 2 or more moderate risk factors for preeclampsia according to US Preventative Services Task Force (2021)
  • Recommendation for 162mg aspirin daily during pregnancy
  • Female aged 16 to 55 years old
Not Eligible

You will not qualify if you...

  • Contraindication to aspirin use
  • Current or planned use of any other blood thinning medication
  • Thrombocytopenia or other known platelet or bleeding disorders
  • Abnormally high baseline PFA-100 epinephrine closure time before starting aspirin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19060

Actively Recruiting

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Research Team

R

Rupsa C Boelig, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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